Project Management for Product Development of Medical Devices
This four day course focuses on project management, and includes references to terms, standards, tools and techniques from product development and the medical device industry.
This project management course provides a high-level overview of the project process for developing a medical device as well as the tools and techniques needed to get through a project. The course has an integrated approach to project management and design control requirements. Topics include what level of documentation is required, how to define requirements, what requirements must be met in order to CE mark a product, how to budget and schedule to avoid cost and schedule overruns. Where risk analysis and usability should be introduced into a product development project are also addressed in the course.
All the contents of the design control course are included in this course.
Who should attend?
Instruction is targeted towards:
- R&D engineers wanting to become project managers
- consultants working with medical device projects
- project managers from other industries that have moved to the medical device industry
- medical device industry project managers
- managers working directly or indirectly with projects and product development
Recommended minimum pre-requisites for this course are any or all of the following:
- experience with product development in a regulated industry
- experience from working in project organisation, or with ISO 13485/21 CFR 820
The learning goals are:
- to advance the ability to successfully initiate, plan, execute, control and close a medical device product development project.
- to provide pragmatic methods, tools and techniques which will boost the ability to finish projects on time and on budget.
- to improve understanding of how and why design control requirements should be implemented.
- to increase knowledge on the most common pitfalls in medical device product development and how to avoid them.
The course comprises lectures, interactive check-points and workshops. The instructor will follow up on learning objectives throughout the course. This means that participants will have to answer questions on the topics covered to ensure that the objectives are met. Active participation and at least 75% attendance is required to be eligible for course certificates.
The course will be conducted in English.
Peter Sebelius, Gantus AB
"Highly relevant professional content from the latest revision of standards and regulatory requirements combined with tips and tricks in relation to practical application"
"Material was very good. Execution of the course was great including planning, activities, workshop and engagement"
"Planning was exemplary. Detailed and punctual"
"Very precise planning which was very helpful"
Participants, Fall 2019